Charged with the responsibility for validation, you will be confronted with a plethora of standards, guidelines, terms and techniques. Understanding the language and the various validation methodologies (along with when and where to use them), is essential for success in this rapidly changing environment.
There are many different paths you can take to achieve a validated state. Sometimes you get there by good luck, sometimes you make a few wrong turns. This training course looks at the tools you need to navigate the various validation pathways you can take to make sure you get it right first time.
You will learn about successful validation through:
- Validation planning
- Product validation life cycle
- Protocol and report writing
- Validation execution
- Statistics that prove validation
- And maintaining the validated state
This course has been designed for validation professionals as well as those involved in approving validation plans and projects. It also applies to anyone interested in GMP and the latest trends and methodologies in validation that are rapidly becoming industry standards.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will delivered as 4 x 3.5 hour sessions over 4 days. Each 3.5 hour session will include a break.
PDF Certificates will be provided to participants electronically.
Each participant will attend four half-day sessions:
|Day 1||11th May 2020||8:30am join for 9:00am-12:30pm|
|Day 2||12th May 2020||8:45am join for 9:00am-12:30pm|
|Day 3||13th May 2020||8:45am join for 9:00am-12:30pm|
|Day 4||14th May 2020||8:45am join for 9:00am-12:30pm|
Times are based on Melbourne, Sydney and Brisbane; Australian Easter Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00
Participants to join at 8:30am in advance of a 9:00am start on day 1, giving time to address any technical issues. There will be a break during each session and we anticipate each session to finish at 12:30pm.
Fee and Discount
- AUD $1,000 (exc. GST) per participant
- A 10% discount applies for 3 or more participants from the same company
What Do I Need?
Participant needs are very basic. You will need a computer with a good internet connection and preferably a headset (headphones with microphone) but alternatively you can dial-in via phone line. Using your computer's built-in microphone may cause problems. The ideal setup includes a second screen/monitor but this is not required.
Contact us for clarification or to discuss your interest in a private delivery of this course on-site or in a virtual-classroom.